Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus
NCT ID: NCT00107107
Last Updated: 2015-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
190 participants
INTERVENTIONAL
2002-11-30
2005-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pramlintide Acetate
Pramlintide acetate injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The concentration of pramlintide injection to be used in this study is 0.6 mg/mL.
pramlintide acetate
Syringe vial and Pen-cartridge
Interventions
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pramlintide acetate
Syringe vial and Pen-cartridge
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Porter, MD
Role: STUDY_DIRECTOR
Amylin Pharmaceuticals, LLC.
Locations
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Research Site
Tempe, Arizona, United States
Research Site
Concord, California, United States
Research Site
Fresno, California, United States
Research Site
San Diego, California, United States
Research Site
San Mateo, California, United States
Research Site
Santa Barbara, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Aventura, Florida, United States
Research Site
Fort Myers, Florida, United States
Research Site
New Port Richey, Florida, United States
Research Site
Tallahassee, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Detroit, Michigan, United States
Research Site
Grand Rapids, Michigan, United States
Research Site
City of Saint Peters, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
Durham, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Camp Hill, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Irving, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Renton, Washington, United States
Countries
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References
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Kovatchev BP, Crean J, McCall A. Pramlintide reduces the risks associated with glucose variability in type 1 diabetes. Diabetes Technol Ther. 2008 Oct;10(5):391-6. doi: 10.1089/dia.2007.0295.
Other Identifiers
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137-150E
Identifier Type: -
Identifier Source: org_study_id
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